Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.

Criteria

Inclusion Criteria:

• Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;

• At least 1 measurable lesion.

• ECOG score 0 or 1;

• Life expectancy of ≥ 3 months;

Exclusion Criteria:

• Known hypersensitivity to any ingredient of TWP-102;

• Receiving any anti-cancer drugs within 4 weeks;

• History of serious systemic diseases;

• History of serious autoimmune diseases;

• Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prior anti-cancer therapy. (except alopecia)

• Pregnancy or lactating women.